Process and apparatus for managing medical device selection and implantation

ABSTRACT

A method of selecting an instrument set for an orthopedic implant procedure. The method utilizes a computer programmed with a data structure configured to store (i) a set of implant components and implant instruments; and (ii) a set of surgical instruments utilized in performing the procedure. The method selects a sub-set of implant components and implant instruments based upon a determination of component types and then selects a sub-set of surgical instruments based upon a determination of surgical techniques. The method arranges the sub-set of surgical instruments and implant instruments into a substantially specific order based upon a determination of a sequence of bone cuts to be performed in the procedure.

I. CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit under 35 U.S.C. § 119(e) to U.S.Provisional Application Ser. No. 62/098,877 filed on Dec. 31, 2014,which is incorporated by reference herein in its entirety.

II. BACKGROUND OF INVENTION

The implantation of artificial joints typically involves a highlycomplex procedure of sizing, aligning, cutting, etc. in order toproperly implant the artificial joint (hereinafter “implant”). To carryout this procedure, most implant manufactures provide a complex set ofcomponents and instruments over a range of sizes, from which the surgeonwill likely need to select in order to accommodate the individualpatient. The sheer number of components and instruments involved in theimplant procedure has led to surgeons often preferring to haverepresentatives of the implant manufacture assist in selecting andpreparing the components and instruments for surgery. A system whichstandardizes, streamlines and organizes the number and types ofcomponents and instruments which must be transported into the operatingtheater would be a significant improvement in the art. Such a systemwould also reduce the possibility of the incorrect instrument (e.g., anincorrect cutting guide, sizing trial, etc.) being utilized duringsurgery. Additionally, it would be a significant improvement to providea system which assists surgeons and other healthcare personnel to moreefficiently use patient data in selecting implant sizes and types,tracking and maintaining an efficient inventory of implantcomponents/instruments, and assisting surgery personnel in the efficientdeployment of implant components/instruments during surgical procedures.

III. SUMMARY OF SELECTED EMBODIMENTS OF INVENTION

One embodiment of the invention is a method of selecting an instrumentset for an orthopedic implant procedure to be performed on a patient bya physician. The method utilizes a computer programmed with a datastructure configured to store (i) a set of implant components andimplant instruments; and (ii) a set of surgical instruments utilized inperforming the procedure. The method selects a sub-set of implantcomponents and implant instruments based upon a determination ofcomponent types and then selects a sub-set of surgical instruments basedupon a determination of surgical techniques. The method arranges thesub-set of surgical instruments and implant instruments into asubstantially specific order based upon a determination of a sequence ofbone cuts to be performed in the procedure.

Another embodiment of the invention is a method of managing implants.The method provides (i) an implant storage space, (ii) a storage sensorlocated proximate the storage space, the storage sensor configured todetect implant components, and (iii) a system computer communicatingwith the storage sensor. The method determines a set of implantcomponents scheduled to depart the storage space, removes from thestorage space the set of implant components scheduled to depart thestorage space, and operates the storage sensor to communicate to thecomputer system that the set of implant components have been removedfrom the storage space.

A further embodiment of the invention is an implant management systemwhich includes an implant storage space and a storage sensor locatedproximate the storage space, where the storage sensor is configured todetect implant components. The management system also includes adeployment sensor configured to detect implant components and a systemcomputer communicating with the storage sensor and the deploymentsensor. The system computer will have software configured to carry outthe steps of: (i) receiving data representing a set of implantcomponents scheduled to depart the implant storage space; (ii) receivingdata indicating that the storage sensor has detected the set of implantcomponents; and (iii) receiving data indicating that the deploymentsensor has detected the set of implant components at a scheduleddestination.

A further embodiment of the invention is a method of predicting arequired size of an implant component utilizing a computer system. Themethod establishes on a user interface of the computer system a medicalimage of an anatomical part on a computer selectable coordinate system.The method allows a user to select multiple points on the coordinatesystem corresponding to specific anatomical features on the medicalimage, and then determines an anatomical distance between at least twoof the multiple points selected by the user. Then the method comparesthe anatomical distance to a database which cross-references specificanatomical distances with a corresponding size of implant component.

Another embodiment of the invention is a method of selecting aninstrument set for an orthopedic implant procedure to be performed on apatient by a physician. The method provides a computer system which isprogrammed with a data structure configured to store: i. a set ofimplant components and implant instruments; and ii. a set of surgicalinstruments utilized in performing the procedure. The method receivesfrom a user interface computer an implant component size estimated forthe patient and generates a sub-set of implant components and implantinstruments based at least in part upon the implant component sizeestimated for the patient. The method generates a visual list of thesub-set of implant instruments in a specific order; and physicallyarranges the implant instruments substantially in the specific order inpreparation for the implant procedure.

The foregoing is a summary of only a few embodiments and the inventionincludes many other embodiments, some described in the below detaileddescription and other not specifically described herein.

IV. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flow chart illustrating one embodiment of an overall processfor determining a reduced set of implant components and instruments.

FIG. 2 is a flow chart illustrating one embodiment of a process foridentifying key anatomical points of a bone joint.

FIG. 3 illustrates one embodiment of a system for identifying keyanatomical points on a medical image.

FIG. 4 illustrates selected anatomical features of a human leg boneutilized in certain embodiments of the present invention.

FIG. 5 is a flow chart illustrating one embodiment of a process forsizing a femoral implant component.

FIGS. 6A to 6C illustrate selected features on an anterior-posteriorview of the distal end of a femur.

FIGS. 7A to 7C illustrate selected features on an medial-lateral view ofthe distal end of a femur.

FIG. 8 is a flow chart illustrating one embodiment of a process forsizing a tibial implant component.

FIGS. 9A and 9B illustrate selected features on an anterior-posteriorview of the proximal end of a tibia.

FIG. 10 illustrate a tibial component sizing chart.

FIGS. 11A to 11C illustrate selected features on an medial-lateral viewof the proximal end of a tibia.

FIGS. 12A to 12C are a flow chart illustrating one embodiment forselecting implant components and related instruments utilized in a totalknee arthroplasty.

FIGS. 13A to 13B are a flow chart illustrating one embodiment forselecting surgical instruments utilized in a total knee arthroplasty.

FIG. 14 is a flow chart illustrating one embodiment of bone cuttingsequences utilized in a total knee arthroplasty.

FIG. 15A is a panel providing information on implant and surgicaldetails.

FIG. 15B is a panel providing information on surgical cuts andinstrument organization.

FIG. 15C is one embodiment of a summary chart which could be displayedon an operating room monitor.

FIG. 15D is one embodiment of a detailed instrument list with instrumentimages which could be displayed on an operating room monitor.

FIGS. 16A to 16J are panels illustrating instrument ordering in oneembodiment of the invention.

FIG. 16K is an example of a label which could be fixed to an instrumenttray.

FIG. 17 is a system bock diagram showing components of an overallimplant selection and deployment system.

FIG. 18 illustrates one embodiment of a computer enabled cabinet forstoring and tracking implant components and instruments.

FIG. 19A is a block diagram of electronic components associated with thecabinet of FIG. 18.

FIG. 19B is a block diagram of electronic components associated with acart used in conjunction with the cabinet embodiment of FIG. 18.

FIGS. 20A to 20C are flow charts illustrating the functionality ofcomputer enabled cabinet of FIG. 18.

FIG. 21 is a high level flow chart illustrating certain embodiments ofimplant inventory control and implant deployment to an operating room.

FIG. 22 is a flow chart illustrating one method embodiment for bookingsurgery.

FIG. 23 is a flow chart illustrating one method embodiment for orderingimplant inventory.

FIG. 24 is a flow chart illustrating one method embodiment for addinginventory to an implant cabinet.

FIG. 25 is a flow chart illustrating one method embodiment for verifyingimplant inventory.

FIG. 26 is a flow chart illustrating one method embodiment fortransferring implant inventory to a deployment cart.

FIG. 27 is a flow chart illustrating one method embodiment for verifyingand preparing implant instruments.

FIG. 28 is a flow chart illustrating one method embodiment for deployingimplant components and instruments during surgery.

FIG. 29 is a flow chart illustrating one method embodiment forpost-operative processing of implant and surgical instruments.

V. DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

One embodiment of the present invention includes a method of selectingan instrument set for an orthopedic implant procedure to be performed ona patient by a physician. In many embodiments, the implant device is fora joint such as the knee, hip, elbow, or shoulder, but could be forother bone joints or for implants unrelated to bones, such aspacemakers, stents, or soft tissue repairs of the shoulder and knee(e.g., implant components and instrumentation used in rotator cuffrepair and/or ACL repair). “Implant procedure” as used herein means anymedical procedure to implant, adjust, correct, or supplement an implantcomponent in a human (or other animal) body. The methods and apparatusesdescribed herein are intended to apply to existing and future developedimplants and procedures. Many of the figures describe the method interms of a total knee implant or total knee arthroplasty, but assuggested above, the method could apply equally to implants for otherareas of the body. Certain of the described embodiments function toorder a subset of “surgical instruments” and “implant instruments” whichare associated with “implant components,” all of which are definedbelow. Other embodiments function to assist in implant componentinventory control and to assist operating room (OR) personnel in thedeployment and implantation of the components.

As used herein, an “implant component” means a thing (e.g., a piece oftissue, prosthetic device, or other object) implanted in a human (orother animal) body as part of a surgical procedure and intended toremain in the body, temporarily or permanently, after the surgicalprocedure. As one nonlimiting example, implant components for a totalknee arthroplasty could include a femoral component, a tibial component,and a patellar component. These components are provided in a range ofsizes and configurations. For example, the femoral implant component maybe “cruciate retaining” or “posterior stabilized,” the tibial baseplatemay be “modular” or “non-modular,” and the patella component may be“onset” or “inset.” A modular tibial component is formed of a tibialbaseplate and a separate insert, while a non-modular tibial component isa single, unitary piece. Many implant components vary based upon bearingdesign, materials, and bone-implant fixation method, e.g., whether theimplant components are affixed with cement or not cemented. A morecomplete listing of various implant components for one particularimplant system is seen in Tables A1.1 to A1.23 in Appendix A, whichappears in the related U.S. provisional application Ser. No. 62/098,877,filed on Dec. 31, 2014, which is incorporated by reference herein in itsentirety. All reference herein to tables designated with the letter “A”(e.g., A1.1, A1.2, A2.1, etc.) refer to the Appendix in U.S. Ser. No.62/098,877.

An “implant instrument” means a device generally in strict accordancewith the type of implant being inserted and is typically supplied by animplant manufacture as an accessory to the implant components. Implantinstruments are generally utilized to shape or facilitate theappropriate anatomy to fit the implant components. The femoralcomponent, tibial component (baseplate and insert), and patellarcomponent will have associated implant instruments. As one nonlimitingexample, implant instruments for a total knee arthroplasty could includefemoral trials, tibial baseplate trials, tibial insert trials, patellacomponent trials, starters, gauges, bone files, bone alignment guides,femoral component sizers, CR Femoral component trials, CR femoralcondyle drills, CR femoral component drivers, PS femoral componenttrials, PS notch cutting jigs, PS reamers, femoral trial componentdrivers, tibial insert trials, tibial insert component impactors, tibialdrill guides, tibial punches, tibial insert trials, patellar drillguides, patellar trials. In general, implant instruments may include anyinstrument for component sizing, bone shaping, component preparation, orimplanting (e.g., tools for alignment in the sagittal, coronal, andaxial planes. A more complete listing of implant instruments for aconventional Total Knee System is seen in Tables A2.1 to A2.18.

A “surgical instrument” means a device the surgeon employs to organizeand effect the surgical outcome, particularly in relation to implantprocedures, but which is typically not considered an implant instrument.Surgical instruments include but are not necessarily limited to bonecutting and alignment instruments. As one nonlimiting example, bonecutting instruments for a total knee arthroplasty could include cuttingguides, alignment guides, resection cutting guides and generallyinstruments for joint extremity alignment, balancing, measuring, andconfiguring. A more complete listing of surgical instruments suitablefor use with a conventional implant system is seen in Tables A3.1 toA3.15.

Many of the figures of the present application illustrate methods andsystems in terms of flow charts. It will be understood that the methodsmay be implemented by software running on a general purpose computerincluding a CPU, a user interface, and requisite memory components. Ageneral purpose computer may include hand-held computers such as smartphones, particularly when a user is interfacing with other devices inthe overall system.

FIG. 17 is a block diagram suggesting various components of oneembodiment of the overall system 300 for carrying out the variousmethods described in this application. The general system 300 maysometimes be referred to herein by the trademark SIGHT™, e.g., the SIGHTsystem. In this embodiment, there is a central server 301 which willtypically be remotely located from the other elements of the system.Most of the other elements seen in FIG. 17 are located at a hospital orother medical facility where the implant surgery is to be conducted.Thus, FIG. 17 shows a hospital network 303 and a “local” SIGHT server302 located in the hospital and in communication with the central SIGHTserver 301, for example through the hospital network 303. Although FIG.17 only shows one set of elements which would generally be located at aparticular hospital, it will be understood that the SIGHT central server301 would be communicating with many different hospital networks 303nationwide or even worldwide, with each hospital having a SIGHT localserver 302. Where this application describes a “computer” or “computersystem,” these terms may include, as examples, central server 301, localserver 302, or the two servers acting together as a single computersystem.

Other system elements typically located in each hospital include one ormore computer enabled cabinets 307 for holding and assisting in themanagement of the implant components and instruments. In thisdisclosure, the cabinets may be referred to by the trademark ODOC™,e.g., “ODOC cabinets” which are explained in greater detail below. Inmany embodiments, the SIGHT local server 302 is housed within the ODOCcabinet 307. Several other elements will communicate (typically througha wireless link such has the hospital's Wi-Fi system forming part of thehospital network 303) with the SIGHT local server 302. These otherelements could include one or more computer displays 304 located inoperating rooms, bar code scanners or RFID tag readers 305 located inplaces such as the ODOC cabinet and the hospital's operating room (OR).Alternatively or in addition to the bar code scanners or RFID readers,image analysis camera(s) 306 may form part of the overall system. Wherethe term “server” is used in the application, it is intended to mean inthe broadest sense any general purpose or special purpose computer whichcan perform the functions described herein.

Normally each physician participating in the SIGHT system will have aphysician interface 308 allowing physicians to send and receiveinformation for carrying out the methods and object described herein. Asone example, the physician interface could be the physician's smartphone or tablet running an app establishing communication with the SIGHTcentral server 301 and possibly with the local server 302 though thehospital network 303.

Examples of the functionality of the SIGHT system suggested by FIG. 17can be seen starting with FIG. 1. FIG. 1 is a comparatively high-levelflow chart illustrating a series of steps taken in one example processfor obtaining implant sizing information and selecting a narrowed set ofimplant components and implant instruments most likely to be utilized inthe implant procedure being contemplated. Step 3 in FIG. 1 suggests howthe process begins with identifying key anatomical points related to thebone joint or other body part being replaced or corrected with theimplant. This step is shown in more detail in the flow chart of FIG. 2.In step 14, a medical image on a radiological monitor or other type ofmonitor is overlayed or superimposed on a computer selectable coordinatesystem, which may be a system forming a grid based upon individualpixels or groups of pixels allowing a user to select “points” on theimage (image coordinates) with a mouse controlled cursor or touch screentechnology. As used herein, “medical image” means any conventional orfuture developed technique for imaging body parts, including x-rays,MRIs, CT scans, and ultrasound. FIG. 3 illustrates conceptually an x-rayof human legs overlayed on the computer grid 24. At step 22 of FIG. 2,the user is prompted as to whether to utilize a user guided procedurefor identifying selecting key anatomical features or to allow thesoftware to perform an image recognition-based algorithm in order toidentify the anatomical features. In the user guided procedure, step 15of FIG. 2 prompts the user to register the scale of the medical image.For example, FIG. 3 shows the scaling marker 35 which allows thecomputer grid scale to be correlated with the medical image scale. Instep 16, the user employs the scaling marker to size the medical imageto the computer grid scale as is well known in conventional imageviewing software. As suggested in step 17 and FIG. 3, the methodincludes displaying on the monitor adjacent to the medical image arepresentation of the anatomical points of interest. For example, FIG. 3shows images illustrating the location of the center of the femoral head(image 30), the tip of the greater trochanter (image 31), the center ofthe femoral notch (image 32), the center of the proximal tibia (image33), and the center of the ankle (image 34). Using these images asguides, the user may “click” on the corresponding anatomical point onthe medical image as suggested by the markers showing the center of thefemoral head 26, the tip of the greater trochanter 25, the center of thefemoral notch 27, the center of the proximal tibia 28, and the center ofthe ankle 29. As an alternative procedure, FIG. 2's steps 18-20 couldemploy a feature recognition algorithm which automatically identifiesthese series of points, e.g., algorithms such as those found in TheMathworks Inc.'s computer vision system toolbox. Regardless of whichprocedure is utilized to identify the anatomical features or points ofinterest, a final step (21) in the method will have the user (e.g., thesurgeon ultimately responsible for the implant procedure) validate thecorrectness of anatomical points selected and any measurements resultingtherefrom. Although the above example describes an image with a scalingmarker, there are medical image formats which do not necessarily requireany scaling, e.g., images conforming to the Digital Imagining andCommunications in Medicine (DICOM) format.

One anatomical characteristic which may be derived from the identifiedanatomical points is the degree of varus or valgus deformity suffered bythe knee which is the subject of the medical image (step 5 in FIG. 1).FIG. 4 illustrates one method the system could use for determining thedegree of varus or valgus deformity. A first line or the “femoralmechanical axis” (“FMA”) is defined as the line between the center ofthe femoral head (CFH) and the center of the femoral notch (CFN). Asecond line or the “tibial mechanical axis” (“TMA”) is defined as theline between the center of the proximal tibia (CPT) and the center ofthe ankle (CA). Because the FMA and TMA are created on theelectronically rendered grid system, the relative angle between the FMAand TMA may readily be determined by the computer system.

This angle between the FMA and TMA is ultimately utilized to determinethe degree of valgus or varus deformity. As a matter of convention,whether a knee has a valgus or varus deformity is determined by therelative position of the knee joint center (“JC”) relative to the weightbearing axis (“WBA”) of the leg. The WBA is defined as the line runningbetween the CFH and the CA. A neutrally aligned leg (no measurable varusor valgus deformity) will have the FMA and TMA running colinearlythrough the WBA. Where the JC is lateral to the WBA, the deformity isconsidered varus. Where the JC is medial to the WBA, the deformity isconsidered valgus. In the FIG. 4 embodiment, the degree of deformity iscalculated by first determining the hip-knee-ankle (“HKA”) angle, whichmay be defined as the lateral angle formed by the FMA and TMA.Thereafter, the absolute value the HKA angle minus 180° is defined asthe degree of deformity. FIG. 4 suggests the WBA having been alignedwith the vertical axis of the grid system, but this is not strictlynecessary since the computer system may calculate the HKA angleregardless of the relative orientation of the WBA and other linesinvolved.

Returning to FIG. 1, step 6, the next basic implant parameter to bedetermined is the femoral component size. Different example methods fordetermining this parameter are illustrated in FIGS. 5 to 7. FIG. 5, step42 begins with prompting the user to select one of two methods fordetermining a distance related to the femoral component size. Bothmethods are based upon registering key points of interest for the femur,for example by using the electronic grid system described in referenceto FIG. 3. In the method of step 43, an anterior-posterior (“AP”)distance is used to determine femur size. FIG. 6A illustrates an AP viewof the distal femur end 50 where the user will register two points instep 45, the anterior femoral resection level 51 and the posteriorcondyle border 52. Thereafter, in step 47 of FIG. 5, the systemcalculates the femoral component size. In this calculation, the distancebetween points 51 and 52 (shown in FIG. 6A as the distance BC along theanterior-posterior line) is added to the thickness of the anteriorflange 55 (FIG. 6B) of the femoral implant component 54. This distanceAC in FIG. 6B is then utilized to find the closest “AP distance” shownin the femoral AP sizing chart of FIG. 6C. For example, if the distanceAC were 59 mm, then the using the sizing chart in FIG. 6C, the systemwould estimate a size 3 femoral component.

An alternative method is disclosed in step 44 of FIG. 5. In this step,the points suggested in FIG. 7A are utilized. These points are themedial posterior condyle border 58 and the lateral posterior condyleborder 59, which are typically recognizable in a medial/lateral medicalimage of the distal femur end (as suggested by dashed lines in FIG. 7A).In step 45 of FIG. 5, the user registers the medial posterior condyleborder 58 and the lateral posterior condyle border 59. The systemmeasures this distance (illustrated as distance DE in FIG. 7B) which isreferred to as the medial-lateral or “ML” distance of the distal femoralend. In step 47 of FIG. 5, the system utilizes the determined distanceDE to find the closest “ML distance” shown in the femoral ML sizingchart of FIG. 7C. For example, if the distance ML were 65 mm, then theusing the sizing chart in FIG. 7C, the system would estimate a size 3femoral component.

Once the femoral component size is calculated or estimated, FIG. 1, step7 determines the tibial component size. This selection process is shownin more detail in FIGS. 8 to 11. FIG. 8 suggests how the user may selectin step 60 one (or both) of two alternative techniques for estimatingthe tibial base plate size. The first alternative is determining directAP measurement of the tibial plateau which is best understood withreference to FIG. 9A. FIG. 9A suggests the user selecting (step 62 a ofFIG. 8) the posterior border 71 of the tibial plateau and the anteriormedial border 72 of the tibial plateau. The system then determines thedistance between these points in step 63 a. The measured “AP” distancebetween points 71 and 72 is then correlated with the “AP” distance onthe tibial base plate as suggested in step 64 of FIG. 8 and FIG. 10. Thebase plate size is estimated by finding the closest standard AP distance(for the different base plate sizes as shown in the chart of FIG. 10)corresponding to the measured AP distance between points 71 and 72. As anonlimiting example, if the measured AP distance between points 71 and72 were 46 mm, then base plate size 3 having the standard AP distance of47 mm would be the estimated base plate size. FIG. 9B illustrates howthe AP distance on the tibial plateau may be measured from an axial viewof the tibial plateau, e.g., an axial view generated from a MRI orsimilar technique. Again, the user is able to select anatomical pointscorresponding with the posterior border 71 and the anterior medialborder 72 of the tibial plateau.

FIG. 9A also suggests an alternative method for measuring the APdistance by utilizing the “tibial canal axis” 78. The tibial canal axisis a line running lengthwise along the center of the tibia. The tibialcanal axis will be located by a user selecting four points 77A to 77Dalong the tibial medial borders as shown in FIG. 9A. The tibial canalaxis 78 is calculated as the line running through the midpoints betweenline 77A-77C and line 77B-77D. The tibial canal axis is extended tointersect (at point B) the line AC between the posterior medial border71 and the anterior medial border 72 of the tibial plateau. The APdistance for the sizing chart may then be calculated as five times thedistance BC or 5/4^(th) the distance AB.

An alternative measurement technique is seen in steps 62 b and 63 b ofFIG. 8 where a medial to lateral measurement is made across the tibialplateau. FIG. 11A illustrates how the user will select (step 62 b inFIG. 8) the lateral most point 80 on the tibial plateau and the medialmost point 81 on the tibial plateau, allowing the system to compute ameasured ML distance from the medical image in step 63 b. This can againbe compared to the closest standard ML distance on the various sizes oftibial base plates as suggested in FIG. 11C, thereby rendering anestimated base plate size as per step 64. FIG. 11C illustrates how thesame points may be selected on an axial view of the tibial plateau inorder to obtain the measured ML distance.

Once the estimated tibial base plate size is determined in step 64 ofFIG. 8, the user is prompted to verify the estimated size in step 65. Inother words, the user, e.g., the surgeon performing the implantprocedure, is expected to use his or her professional judgment toconfirm that the implant size estimated by the algorithm is consistentwill of the particular patient details known to the surgeon and thesurgeon's overall experience with implant procedures.

A determination of patellar component size (if necessary) is made instep 8 of FIG. 1. The surgeon may measure the width and/or thickness ofthe patient's patellar or the surgeon may estimate a patellar componentbased upon his or her judgement considering the size of the femoral andtibial components. In some implant procedures, the patient's existingpatellar may be utilized with the implanted femoral and tibialcomponents.

Once femoral component size, tibial component size, and patellarcomponent size have been estimated, FIG. 1, step 9 involves thecondensing, i.e., reduction in the number of components, of the implantcomponents and implant instruments. FIGS. 12A to 12C illustrate onemethod for selecting certain implant components and implant instrumentsbased upon certain information such as “patient metrics” and “implantcomponent types.” In one embodiment, “patient metrics” means patientanatomical information relating to an implant procedure. As onenonlimiting example, patient metrics for a total knee arthroplasty couldinclude patient age, sex, extremity (e.g., left knee/right knee),initial deformity, activity level, insert constraint, and component sizerange. As suggested in the above FIGS. 5 and 8, the system may determinean estimated femoral component size and tibial component size, e.g.,size 4 for the femoral component and size 3 for the tibial component.The “component size range” would typically be the next size above andbelow the estimated component size, e.g., 3, 4, and 5 for the femoralcomponent and 2, 3, and 4, for the tibial component. It is a commonpractice to prepare for surgery not only the single most likelycomponent size, but also a size above and below. This practice addressesthe possibility that upon accessing the joint and cutting/shaping thefemur or tibia, the surgeon will determine that the component size aboveor below the initially estimated is the better size selection.

Further patient metrics could include patient clinical presentations,initial limb deformity analysis, boney architecture, (e.g., bonevalgus/varus degree measurement as described above, overall bone healthand/or need for additional implant component augments), and potentialcomplicating factors (e.g., previous surgeries). For purposes ofdescribing one embodiment in reference to FIGS. 12 to 16, the followingpatient metrics will be assumed: Age: 62; Sex: Male; Extremity: RightKnee Joint; Initial Deformity: 12° Valgus; Activity Level: ModeratelyActive; Insert Constraint: PS Standard; Femoral Component Size Range: 3,4, 5; Tibial Component Size Range: 2, 3, 4; Patellar Component SizeRange: 32 mm, 35 mm, 38 mm. “Implant component type” means a variationof implant type/style. As one nonlimiting example, component types for atotal knee arthroplasty could be (i) post stabilized vs. cruciateretaining in regards to femoral components, (ii) modular metal-back vs.monblock metal-back for tibial components, (iii) standard, deep flex, orconstrained for tibial insert components, and (iv) onset vs. inset forpatellar components. Both femoral and tibial components may havecemented and uncemented variations.

In the initial step 115 seen in FIG. 12A, the patient metrics for thepatient receiving the implant are determined. In this embodiment,“determining” or “determination” means reaching a decision or obtaininga needed value or other information. For example, a program receivinguser input of a requested value (e.g., through a drop down menu) isconsidered a “determination” of that value. Likewise, valuespre-existing in a database and directly accessed by a software programcan also be a “determination.” Examples of determinations made in thedisclosed embodiments include providing an implant component type (e.g.,posterior stabilized or cruciate retaining femoral components), animplant instrument type (e.g., standard, deep flex or constrained tibialinsert type), or a surgical instrument type (e.g., milling device,resection guide and power saw only for the patella resurfacingtechnique). Naturally, this list is merely illustrative and many other“determinations” of relevant information would be made in obviousvariations of the currently described embodiments. For the purposes ofthe FIG. 12A embodiment, it is assumed a that a determination has beenmade to use a fixed bearing, non-constrained implant type.

In many embodiments, it is contemplated that patient metrics would beinitially uploaded to the SIGHT system by the patient's surgeon or othertreating physician via a physician interface such as suggested in FIG.17.

In FIG. 12A, after receiving or “determining” the patient metrics instep 115, step 116 determines whether the femoral component type will be“post stabilized” or “cruciate retaining” (e.g., a decision, like othersregarding implant type, made by the surgeon in consultation with thepatient prior to implantation). This decision results in the selectionof implant components and implant instruments (step 117 or 118)associated with the selected femoral component type. For example,assuming posterior stabilized (“PS”) is selected, then the range offemoral implant components is narrowed to those seen in tables A1.3 andA1.4 and those cruciate retaining (“CR”) implant components seen intables A1.1 and A1.2 may be eliminated from consideration. Likewise,certain implant instruments such as the CR Femoral Trials in tables A2.3and A2.4 may be eliminated from consideration. Additionally, the patientmetrics provided size information and left/right selection, allows afurther narrowing of potential implant components. In step 119, adetermination is made as to whether the femoral component will becemented or uncemented (with a similar determination made in step 118 ifcruciate retaining was chosen). FIG. 15A lists the selections determinedin the steps seen in FIGS. 12A to 12C.

Continuing with the earlier example, if a cemented PS femoral componentis selected, step 121 will return a subset of femoral components fromtable A1.3. Assuming patient metrics providing a right side implant anda #4 size, a list of PS cemented femoral implant components as shown inTable 1 below will be identified. As suggested above, in manyembodiments, if a single best estimate size is provided from patientmetrics, the next implant component (and implant instrument) size aboveand below the anticipated size is provided in order to allow these othersizes to be used as alternatives to the initially estimated size. Thus,the identification of size #4 in patient metrics will result in thereturn of sizes #3, #4, and #5 for all implant components and implantinstruments (where size is applicable). Alternatively, a size range maybe provided in the original patient metrics (e.g., see above assumedpatient metrics). At step 121, a determination of a reduced set ofimplants and instruments from tables A1.3, A2.1, and A2.5 may be madeaccording to the below tables 1 and 2:

TABLE 1 PS - Femoral Implant Comp (Cemented). Femoral Component PS,Cemented, #3 right Femoral Component PS, Cemented, #4 right FemoralComponent PS, Cemented, #5 right

TABLE 2 PS - Femoral Implant Instruments (Cemented). Femoral ComponentPS, trial Cemented, #3 right Femoral Component PS, trial Cemented, #4right Femoral Component PS, trial Cemented, #5 right Cemented femoralimpactor PS cutting jig drill guide PS reamer PS Notch cutting jig, #3PS Notch cutting jig, #4 PS Notch cutting jig, #5 PS housing punch PShousing impactor

In FIG. 12B, the selection process continues for the tibial component ofthe implant. Because the assumption in the above example was posteriorstabilized, this example will look at step 125 to determine whether thetibial/insert component type is modular metal-back or non-modularmetal-back. However, it can be seen in FIG. 12B that a parallelselection process takes place beginning at step 126 if cruciateretaining had been selected in regards to femoral type. It will beassumed for purposes of this example, that in step 125 modularmetal-back is selected, reducing the responsive components to TablesA1.5, A1.6, and A1.9 to A1.11. Step 131 again narrows this selectiondown in terms of cemented and uncemented and if cemented is selected,further reduces responsive components to Tables A1.6 and Tables A1.9 toA1.11. The implant instruments are now limited to Tables A2.8 and A2.11to A2.13. A final determination is made in step 137 as to whether thetibial component bearing surface design is “standard” or “deep flex” asseen in Tables A1.9, A1.10, and A1.11, respectively. If “standard” typeis determined, the implant components and implant instruments will be:

TABLE 3 PS - Tibial Baseplate Implant Comp (Cemented). Cemented, Tibialbaseplate #3 Cemented, Tibial baseplate #4 Cemented, Tibial baseplate #5

TABLE 4 PS - Tibial Insert Implant Comp (Cemented). Tibial insert PS,Standard, #3 × 9 mm Tibial insert PS, Standard, #3 × 11 mm Tibial insertPS, Standard, #3 × 13 mm Tibial insert PS, Standard, #3 × 15 mm Tibialinsert PS, Standard, #3 × 18 mm Tibial insert PS, Standard, #4 × 9 mmTibial insert PS, Standard, #4 × 11 mm Tibial insert PS, Standard, #4 ×13 mm Tibial insert PS, Standard, #4 × 15 mm Tibial insert PS, Standard,#4 × 18 mm Tibial insert PS, Standard, #5 × 9 mm Tibial insert PS,Standard, #5 × 11 mm Tibial insert PS, Standard, #5 × 13 mm Tibialinsert PS, Standard, #5 × 15 mm Tibial insert PS, Standard, #5 × 18 mm

TABLE 5 PS - Tibial Baseplate Implant Instruments (Cemented). Cemented,Tibial baseplate trial #3 Cemented, Tibial baseplate trial #4 Cemented,Tibial baseplate trail #5 Tibial baseplate driver Tibial baseplate trialhandle Tibial drill Tibial drill guide Cemented tibial punch handleCemented tibial punch, S Cemented tibial punch, M Cemented tibial punch,L

TABLE 6 PS - Tibial Insert Implant Instruments (Standard). Tibial inserttrial PS, Standard, #3 × 9 mm Tibial insert trial PS, Standard, #3 × 11mm Tibial insert trial PS, Standard, #3 × 13 mm Tibial insert trial PS,Standard, #3 × 15 mm Tibial insert trial PS, Standard, #3 × 18 mm Tibialinsert trial PS, Standard, #4 × 9 mm Tibial insert trial PS, Standard,#4 × 11 mm Tibial insert trial PS, Standard, #4 × 13 mm Tibial inserttrial PS, Standard, #4 × 15 mm Tibial insert trial PS, Standard, #4 × 18mm Tibial insert trial PS, Standard, #5 × 9 mm Tibial insert trial PS,Standard, #5 × 11 mm Tibial insert trial PS, Standard, #5 × 13 mm Tibialinsert trial PS, Standard, #5 × 15 mm Tibial insert trial PS, Standard,#5 × 18 mm Universal Insert impactot Insert extractor

FIG. 12C illustrates the final steps in the implant component andimplant instrument selection process. In step 145, it is determinedwhether the patellar component type is onset or inset. The implantcomponent options are set out in tables A1.22 and A1.23, while theimplant instrument options are seen in tables A2.14 and A2.16. If onsetis determined in step 145, then the returned implant components andinstruments in step 147 are:

TABLE 7 Onset Patellar Implant Components. Patella, onset, 32 mmPatella, onset, 35 mm Patella, onset, 38 mm

TABLE 8 PS - Onset Patellar Implant Instruments. trial, onset, 32 mmPatellar trial, onset, 35 mm Patellar trial, onset, 38 mm Patellar Onset patellar peg drill On set patellar drill guide, 32 mm On setpatellar drill guide, 35 mm On set patellar drill guide, 38 mmIn step 151 of FIG. 12C, all components and instruments in Tables 1 to 8are returned.

FIGS. 13A and 13B illustrate one process which may be utilized inselecting the surgical instruments utilized in the implant procedure.This process is based upon the “surgical technique” utilized by thesurgeon. Examples of surgical techniques which may be utilized in a kneereplacement procedure include joint balancing technique (gap balancingvs. measured resections), distal femoral cut valgus alignment technique(extramedullary, intramedullary, or navigation), tibia cut varus/valgusalignment technique (extramedullary, intramedullary, or navigation), andpatella resurfacing technique (milling device, resection guide, orfree-hand). An exemplary set of surgical instruments which might be usedin conjunction with a conventional implant system are listed in TablesA3.1 to A3.15. In step 160 of FIG. 13A, it is determined what jointbalancing technique is to be utilized. If the gap balancing technique ischosen, step 161 returns the surgeon's preferred gap equalizationinstruments (e.g., AP sizer, AP cutting guide, implant specifictensioners, etc.) and these will correspond to the surgical instrumentsin Table A3.1. If measured resection is chosen, step 162 returns thesurgeon's preferred gap equalization instruments which will correspondto Table A3.2. Assuming measured resection is determined and taking intoaccount the previous patient metrics, step 162 would return theinstruments:

TABLE 9 Measured Resection Femoral Instruments. Femoral sizing &rotation guide, sz 1-7 Ant/Post Ref, 4-n-1 cutting guide, #3 Ant/PostRef, 4-n-1 cutting guide, #3 Ant/Post Ref, 4-n-1 cutting guide, #3Anchoring pins Pin driver

In step 163, it will be determined whether the femoral alignmenttechnique (distal femoral cut) will be extramedullary, intramedullary,or via computer assistance. The instruments related to these selectionsare illustrated in Tables A3.3, A3.4, and A3.5, respectively. Ifintramedullary is determined, step 165 would return the instruments:

TABLE 10 Valgus Alignment Instruments (distal femoral cut). Femoraldrill Femoral IM rod Femoral IM alignment guide Femoral IM valgus guide,right Distal femoral alignment guide Distal femoral cutting guideAnchoring Pins Pin Driver

As seen in FIG. 13B, a similar determination is made in step 167regarding the tibial alignment technique related to the proximal tibialcutting. The cutting may be extramedullary, intramedullary, or viacomputer assistance, with the instruments related to these selectionsbeing illustrated in Tables A3.6, A3.7, and A3.8, respectively. Ifextramedullary is determined, step 168 would return the instruments:

TABLE 11 Varus/Valgus Alignment Instruments (proximal tibial cut).Tibial stylus Tibial cutting guide, right Tibial EM alignment guideTibial alignment rod Anchoring Pins Pin Driver

Next in FIG. 13B, a determination is made in step 171 regarding thepatella resurfacing technique. The resurfacing technique may be via amilling device, resection guide, or a free-hand technique, with theinstruments related to these selections being illustrated in TablesA3.10, A3.11, and A3.12, respectively. If resection guide is determined,step 173 would return the instruments:

Table 12. Patella Resurfacing Instruments (Patella Cut).

Patellar resection guide

Patellar caliper

In step 175 of FIG. 13B, the populating constraints step results in theinstruments in Tables 9 to 12 being returned.

Once the subset of implant components, implant instruments, and surgicalinstruments are selected through the above described process, a furtherseries of steps in the illustrated embodiment accomplishes the orderingthe implant instruments and the surgical instruments. One series ofsteps for ordering the instruments based on the surgeon's preferredsequence of making bone cuts is suggested in FIG. 14. This procedureanticipates different surgeons will make the bone cuts in differentorders. However, for purposes of illustrating one example of utilizingthis process, it will be assumed that the sequence of cutting is: (1)distal femoral; (2) proximal tibial; (3) anterior femoral; (4) posteriorfemoral; (5) anterior femoral chamfer; (6) posterior femoral chamfer;and (7) patellar.

At step 200 in FIG. 14, it is determined which bone and particular cutthe surgeon prefers to make first in the procedure. If the femur isselected (step 204), a further selection of either an anterior femoralcut or a distal femoral cut must be determined, which will return arespective set of instruments in steps 205 or 206. Since distal femoralis being assumed for this example, the instruments would correspond toTable 10 above (which are also seen in FIG. 16A). After this cut, adecision is made at step 207 regarding whether the next cut will be theproximal tibial cut or the anterior/posterior (A/P) femoral cut.Assuming proximal tibial, the logic flow is to step 201 (through step200) which returns the instrument set of Table 11 (FIG. 16B). In step202, a decision is made whether all cuts have been made (cuttingfinished), to proceed to the patella cut, or to proceed to the remainingfemoral cuts. Assuming the next cut to be the remaining femoral cuts,step 208 will return the instruments seen in Table 9 (FIG. 16D). Sincethe tibial cuts have been made, step 209 directs the logic flow to A/Pfemoral chamfer cutting, which in step 210 returns some of the implantinstruments from Table 2 together with the cutting guides from Table 9(FIG. 16F). At step 211, the logic flow moves to the patellar cut instep 212, which returns the instruments from Tables 8 and 12 related tothe patellar cut (FIG. 16G). In step 213, the previously cut flatsection of bone is sized for the appropriate patella implant, with holesbeing drilled using the correct sizing instrument. If no further cutsare to be made in step 214, then in step 215, the final instrument setis returned and ordered as further described with reference to FIG. 15B.

FIG. 15B suggests the order of not only surgical instruments from thelogic of FIG. 14, but also associated implant instruments. For example,after the proximal tibila cutting step, the surgeon will typically makean extension gap check. This involves the series of surgical instruments(see FIG. 16C) such as the extension gap spacer block, the spacer blockalignment rod, and a series of gap gauges (see Table A3.14). Thus, theseimplant and/or surgical instruments will be incorporated into theordered set of instruments. Similarly, after the A/P femoral cut, aflexion gap check is carried out using similar surgical instruments assuggested in FIG. 16E (see Table A3.13). After the patellar cutting andfinishing step, a series of trials are made using all the trialcomponents, i.e., the femoral component, the tibial baseplate, thetibial insert, and patellar trials (see FIG. 16H). Certain othersurgical instruments (e.g., femoral trial component driver, tibialinsert trial impactor and extractor—see Table A3.15) will be associatedwith these trials. Another set of instruments (see FIG. 16I) will beassociated with any tibial finishing. Finally, the instruments seen inFIG. 16J will be provided for the actual implant component fixation tothe prepared femur and tibia.

It should be observed from FIGS. 16A to 16J that certain instruments areused multiple times in the sequence of preparing bone cuts and carryingout the trials. For example, the gap gauges shown in FIG. 16C for theextension gap check are also used in the extension gap check assuggested by FIG. 16E. Likewise, A/P cutting guides seen in FIG. 16D arealso part of the instruments seen in FIG. 16F. Typically, a second setof these repeatedly used instruments is not provided, but rather thesame instruments are used at these different stages of the procedure. Ofcourse, this does not rule out certain embodiments providing redundantsets of instruments.

In certain embodiments, these instruments suggested in FIGS. 16A to 16Jwill simply be provided as an ordered list, e.g., printed out ordisplayed on a monitor (as described in more detail below). In manyother embodiments, the instruments will be placed in some type ofcontainers (e.g., a “surgical trays”) in the specific order illustratedin FIGS. 16A to 16J, in which the instruments are sterilized prior tobeing brought into the operating theater. A conventional surgical trayoften has several “sub-trays” or “layers” which stack one on top of theother within the main surgical tray. These layers may even includedivider spaces which further subdivide the layers into “sections.” Thus,each of FIGS. 16A to 16J are not intended to each represent the contentsof a separate surgical tray. Rather, the sub-sets of instruments inFIGS. 16A to 16J could each be place on separate layers or even separatesections. The instruments may be arranged in a manner that is mostconvenient and efficient given the shape, size, and number ofinstruments while generally following the order seen in FIGS. 16A to16J. It is not necessary that the instruments be place in the exactorder determined by the selection method, i.e., the instruments do notneed to be in the exact order seen in FIGS. 16A to 16J. For example, inFIG. 16A, the femoral drill need not necessarily be placed directly nextto the femoral IM rod or the anchoring pins directly next to the pindriver. It is sufficient that the order of the instruments is“substantially specific” to that determined by the method. Substantiallyspecific means that there is at least a 60% correlation between theinstrument order determined by the method and the instruments as orderedin the surgical trays (or other containers). In alternative embodiments,this correlation could be at least 65%, 70%, 75%, 80%, 85%, 90%, or 95%.This less than exact correlation could also apply if the final result ismerely a list of instruments as opposed to physical trays.

In many embodiments, the trays(s) with the assembledcomponents/instruments will have one or more labels placed on the trays.FIG. 16K illustrates one example of a label 250 which could be appliedto the trays. This example label has blocks 251 for written text such assystem name (e.g., the manufacturer's trademark for the product),version (e.g. “standard”), set # (e.g., which unit of multiple units areavailable at the location), tray name (e.g., “femoral alignment” tray),format or type of system (e.g., “minimally invasive”), manufacturereference number, etc. These labels will also have one or more bar codeswhich associate certain information in the SIGHT system to this label.For example, the “ODOC Assignment” bar code 252 provides information onwhich ODOC cabinet the tray components originate from or are assignedto. The Table of Contents bar code 253 will be associated with a list ofinstruments in the tray. The OR Setup Diagram bar code 254 will beassociated with a diagram illustrating how the instruments should be setup in the OR, e.g., see FIGS. 15C and 15D showing an example of setupdiagrams. Thus, one example the above described method could include thesteps of assembling the implant instruments in a tray and placing a barcode on the tray, where the bar code associates the tray with aparticular instrument order stored in the computer system.

It will be understood that in many embodiments, the instrumentsthemselves will have unique bar codes attached directly to theinstruments. This allows the instruments to be scanned and identified bythe SIGHT system at different steps of the various procedures describedherein. It will also be understood that where bar codes are mentioned,other tracking technologies could be substituted, e.g., RFID tags ratherthan bar codes and RFID readers rather than bar code scanners.

FIGS. 15C and 15D illustrate one example of how the reduced instrumentset may be used to assist an orthopedic implant procedure in anoperating room with a display communicating with a computer system(e.g., OR display 304 and SIGHT local server 302 in FIG. 17). Thecomputer system may loaded with a sub-set of surgical instruments andimplant instruments arranged into a substantially specific order basedupon a determination of a sequence of bone cuts to be performed in theprocedure. The surgical instruments and implant instruments may bedisplayed in the substantially specific order in different formats. Forexample, FIG. 15C provides an overview of the entire procedure listingsequentially information such as the process step number, the instrumentgroup, the cut number, the table of contents reference, and activitytype. Additionally, FIG. 15D suggests how steps may be broken down withimages of the instruments presented in the order of their use. Thisvisual display of the instruments would help less highly skilled ORassistants organize the instruments prior to surgery and would alsoassist the surgeon during surgery to keep track of each successiveinstrument and step to be carried out. Although only two steps are shownin FIG. 15D for the sake of brevity, it will be understood that eachstep in FIG. 15C would be presented in sequence and with instrumentimages on the OR display as suggested by FIG. 15D.

In one embodiment, the above method would include the steps of firstloading on the computer system a sub-set of surgical instruments andimplant instruments arranged into a substantially specific order basedupon a determination of a sequence of bone cuts to be performed in theprocedure. Next would be presented on the display the surgicalinstruments and implant instruments in the substantially specific order.Then on the display, the user would advance through the substantiallyspecific order of the surgical instruments and implant instruments as auser orders the instruments on an operating room table.

A related method embodiment would involve the computer system having adata structure storing (i) a set of implant components and implantinstruments and (ii) a set of surgical instruments utilized inperforming the procedure. The computer system would receive from a userinterface computer an implant component size estimated for the patient,generate a sub-set of implant components and implant instruments basedat least in part upon the implant component size estimated for thepatient, and then generate a visual list of the sub-set of implantinstruments in a specific order. Then the OR assistant would physicallyarrange the implant instruments substantially in the specific order inpreparation for the implant procedure.

In addition to obtaining a reduced instrument set for the implant sizemost compatible with the particular patient (a “simple primary”non-constrained implant system), a severe varus or valgus deformity andother patient specific circumstances may render it is advisable to havea more constrained set of implant components/instruments (revisionimplants) in case the surgeon determines during surgery that a morespecialized implant system is preferable. Thus, FIG. 1, step 12 promptsthe user (surgeon) to determine a backup instrument set. In oneembodiment, the determination of whether and which backup system isadvisable may be made on factor such as set out in Table 13 appearingbelow.

TABLE 13 Complexity/Backup Criteria 1. Simple Primary Implant SystemMinimal Varus/Valgus & Rotational Constraining Prosthesis ConfigurationsNon Constrained Multiple CR & PS Component Options (i.e., Material,Bearing Surface, Fixation, Fit, Function) Modular & Non-Modular TibialComponents 2. Complicated Primary Implant System Minimal Varus/Valgus &Rotational Constraining Prosthesis Non Constrained Configurationsw/augmentation Multiple CR & PS Component Options (i.e., Material,Bearing Surface, Fixation, Fit, Function) Modular & Non-Modular TibialComponents Augmentation Options for Managing Moderate Instability & BoneLoss 3. Complex Primary Implant System Varus/Valgus & RotationalConstraining Prosthesis Semi Configurations Constrained Deep FemoralBox/Cam w/ Large Tibial Post w/augmentation Modular Femoral & TibialComponents (non-hinged) Several Augmentation Options for ManagingModerate to Severe Instability & Bone Loss 4. Standard Revision 5.Complicated Revision Implant System Most Constrainting ProsthesisConfigurations Fully Constrained Axle/Hinge Links Femoral & TibialComponents w/augmentation Modular Femoral & Tibial Components (hinged)Modular Augmentation Options to Manage Global Instability & Massive BoneLoss 6. Complex Revision/Limb Salvage

For example, in the case of a “primary” knee replacement (i.e., thefirst time the patient is receiving a replacement of the knee inquestion), the procedure is likely to be considered a “simple primary”procedure if there is minimal valgus/varus deformity and there are noother complicating factors. In such a case, the surgeon may determinethere is no need for a backup system. On the other hand, in the case ofwhat the surgeon considers to be moderate valgus/varus deformity (e.g.,<15 degrees) and/or moderate instability and bone loss, the surgeon mayconsider the case as a “complicated primary” and opt to have available anon-constrained implant system with augmentation. In other words, theimplant system will have full rotational and medial/lateral freedom ofmovement, but the base portions of the implant components may requiresupporting metal augmentation to compensate for a greater degree of boneremoval during preparation of the knee to receive the implant. In casesof greater degrees of deformity (e.g., >15 degrees) and complicatingfactors as significant existing knee instability and/or bone loss, thesurgeon may consider the case as a complex primary and select asemi-constrained implant system with augmentation. This implant systemprovides medial/lateral constraint (e.g., to compensate for compromisedknee ligaments), but still allows significant rotational freedom.

Another class of knee replacement procedures are “revisions” where thepatient has already had at least one replacement of the knee at issue.For a “standard” revision procedure, i.e., no significant complicatingfactors beyond the replacement of a previous implant, the surgeon maywish to have a semi-constrained implant system as described immediatelyabove. In revision cases where there is very severe bone loss and/ormoderate deformity, the surgeon may consider the case to be a“complicated revision” and opt for fully constrained implant system withaugmentation. This implant system allows the least freedom of movementand is functionally a hinged system. The same backup implant systemwould be selected in a “complex revision” where there is severe boneloss, instability, and a comparatively high degree of deformity(e.g., >15 degrees).

As mentioned above in reference to FIG. 17, one of the components of theoverall SIGHT system is the cabinets 307 or the “ODOC” cabinets. FIG. 18illustrates one embodiment the cabinet 307 having a cabinet body 314with various bins or shelves 318 formed in the cabinet body. A door 317with a computer controlled locking mechanism 322 will control access tocabinet 307. Many embodiments of the cabinet will have a user interfacesuch as the display 315 and input 316. In some embodiments the input 316is the touch screen and forms part of display 315. In other embodiments,the input 316 may be formed of a touchpad or a keyboard/mousecombination. One example of the electronic components which couldcontrol cabinet 307 is seen in FIG. 19A. Thus, there is a CPU orcontroller 320 which communicates with a memory 325, the display 315,and a network interface 324, which again could be a Wi-Fi link to thehospital network. The embodiment of FIG. 19 shows the controller 320interfacing with a keyboard 316A, a mouse 316B, bar code scanner (orRFID reader) 321, door release (or door lock control) 322, and biometricreader 323. The bar code scanner (or RFID reader) 321 may be considereda type of “storage sensor” since it functions to sense or readcomponents stored in cabinet 307. The biometric reader may be anyconventional or future develop device for reading a biometric parameter,e.g., finger print, retina scan, voice recognition, etc. The biometricsensor will typically be used to authorize user access to cabinet 307,i.e., the biometric sensor allowing the controller 320 to identify thepresence of an authorized user and activating the door release.

Although FIG. 18 illustrates a cabinet with a lockable door, otherembodiments could employ any type of implant storage space, whetherenclosed or not. The use of an RFID reader which detects the entry intoor exit from the storage space of a RFID tagged object would reduce theimportance of a lockable enclosure. As alluded to above, the ODOCcabinet controller 320 may in many embodiments act as the local SIGHTserver 302 referenced in FIG. 17.

In many embodiments of the SIGHT system, the ODOC cabinet 307 willoperate in conjunction with a computer enabled cart 330. The cart willallow system users to place trays of implant components from the ODOCcabinet onto the cart for wheeling into the operating room. FIG. 19Bshows the electronic components associated with one embodiment of thecart. Thus cart 330 may include a contoller/CPU 334 operating inconjunction with memory 331, bar code scanner (or RFID tag reader) 333,network interface (e.g., Wi-Fi link) 335, and a user interface includingdisplay 332, mouse 336, and keyboard 337. The bar code scanner 333 maybe considered a type of “deployment sensor” since it is used to sense orread bar codes during the deployment of the implant components andinstruments, i.e., when the cart is in the OR or other location distantfrom the storage cabinet. Additional aspects of cart 330's functionalityare explained in conjunction with the flow charts of FIGS. 20A to 20Cand other figures described herein.

FIG. 20A illustrates a basic operational sequence when a user accessesan ODOC cabinet 307. The log-in step 340 involves the entry of an accesscode or reading of the appropriate biometric parameter by a biometricsensor. The user will select through the user interface in step 341 theintended action, for example removal (i.e., the “take function”) of anitem from the cabinet. In step 342, the user selects the patient(allowing the system to associate a set of implants and instruments witha patient's name) and in step 343 the cabinet controller activates thedoor release. As the user removes each item, the item is scanned in step344. Thereafter, the cabinet door release re-locks and the controllerterminates the functional sequence. In alternative embodiments utilizingan RFID reader rather than a bar code scanner, the cabinet controllercould take RFID reads of the cabinet contents at different times (e.g.,a read before the door release is activated and a read after the doorrelease re-locks). In this manner, the cabinet controller coulddetermine which items were removed from the cabinet during the periodthe door was open.

FIG. 20B illustrates a re-stock function. The function begins with thelog in at step 350 and the selection of the re-stock function in step351. Next, the user designates whether the re-stock will be of thecabinet or the cart. In other words, the cart may have also have astorage space which will hold implant components and instruments, buttypically for a shorter time period than the cabinet. An item to beplaced in the cabinet (or cart) will be scanned (in the bar codeembodiment) in step 353, then placed in the item's proper shelf of binin step 354, and then the process repeated for all items to be placed inthe cabinet (or cart). The function terminates in step 356.

In a related embodiment, since the system computer communicates with thestorage sensor and the deployment sensor, the system software may beconfigured to carry out the steps of: (i) recording a set of implantcomponents departing the implant storage space; (ii) recording the setof implant components when detected by the deployment sensor; and then(iii) generating a restocking request listing the set of implantcomponents departing the storage space. The set of implant componentsdeparting the storage space may be defined by a period of time. Forexample, the set may include those implant components (and/orinstruments) which have departed the storage place over a given periodof time, e.g., over the last 12 hours, 24 hours, or 72 hours. On theother hand, the system could define the set of implants as the groupvery recently removed from the storage space, e.g., the set of implantcomponents departing the storage space over a period of no more than thelast five minutes.

FIG. 20C illustrates a transfer function. After logging in (step 360),the user selects in step 361 the source and destination (cabinet orcart) of the item to be moved. Where the user selects transfer fromcabinet to the cart, step 362 unlocks the cabinet door. In step 364, theitem is removed from the cabinet, scanned in step 366, and placed in thecart in step 367. The process is repeated for all items to betransferred and the cabinet door is re-locked in step 368. If the userselects transfer from the cart to the cabinet, the user in step 363removes the item from the cart and scans the item in step 365 with thecabinet scanner. After the cabinet controller receives the scan data,the controller releases the cabinet door lock in step 369. The userplaces the item on the proper shelf in the cabinet and steps 363 to 370are repeated for all items to be transferred. Once no further scans aremade during the transfer routine, the cabinet remains locked in step 371and in step 372 the controller terminates the transfer routine.

In addition to the determination of a reduced set of implant componentsand instruments, certain embodiments of the present invention includemethods of scheduling the implant surgery, confirming the requiredimplant components and instruments are available, and replenishinginventory. FIG. 21 illustrates a top level workflow in one exampleembodiment. Beginning with step 401, the system captures necessarypatient parameters. These patient parameters may include the patientmetrics previously described (e.g., age, gender, BMI, range of motion,co-morbidity, medical history, etc.). Next in step 402, a surgerybooking procedure is carried out as described in more detail in FIG. 22.Starting with step 420 in FIG. 22, the system prompts the patient'streating physician to create a booking sheet with information such assurgeon, hospital, date of surgery, name/age of patient, procedure type,instruments and implants required, insurance information, etc. In step421, the appropriate surgical team member, for example the sitereadiness manager (SRM) under the supervision of the surgeon, determinesthe key anatomical features in the manner described above. In step 422,the SRM schedules the surgery into the hospital information system(“HIS”), typically reserving an operating room and other detailsrequired for scheduling the surgery. The SIGHT system in step 424collects information from the booking sheet, the key anatomical pointson the medical images, and confirmation of surgery scheduling (step423). With this information, the system generates a suggested kit orreduced set of implant components and instruments, e.g., using themethod previously described in FIGS. 12 to 16. In step 426, the surgeonconfirms the reduced component and instruments set or makes edits to thesame. In certain embodiments, the SIGHT system will record the surgeon'sconfirmation or selection of instruments and make the instrumentselection the default setting for that surgeon and the particularimplant procedure under consideration. Given the confirmed set ofimplant components and instruments, the SIGHT system in step 427compares the required implant components and instruments to theinventory available in the relevant ODOC cabinet. If the inventory isnot currently available in the ODOC cabinet, the SIGHT system places anorder for the inventory in step 428 and finally, places a reservation(step 429) on the selected components and instrument until the scheduledday of surgery.

At step 403 in FIG. 21, the system returns a set of surgical supplies,e.g., sutures, scalpels, retractors, skin prep items, drapes, andsimilar general surgical supplies, based upon a database listassociating such surgical supplies with the particular implantcomponents and instruments selected. In step 404, the system maygenerate an order for implant inventory from a supplier as is necessaryto maintain appropriate component and instrument levels in the ODOCcabinet. For example, in step 435 in FIG. 23, the SIGHT system mayreceive an order request initiated by the surgeon or SRM through theSIGHT system (e.g., step 429 in FIG. 22). In step 436, the SIGHT systemgenerates a purchase order requisition which is received by the hospitalsystem hosting the ODOC cabinet in step 437. The hospital systemapproves the purchase order in step 438 and transmits the purchase orderto the implant supplier in step 439. At the supplier level, the purchaseorder is received, processed (a shipment created), and sent in steps 441to 443, with the hospital and the SIGHT system receiving notice of theshipment in steps 444 and 445. The supplier invoices the hospital forthe shipment in step 447 and provides the invoice information to theSIGHT system in step 448.

In FIG. 21, this embodiment of the SIGHT system shows the systemcommunicating with patients in step 405 confirming date of surgery,giving pre-operative instructions, etc. The hospital will receive ashipment at step 406 and the inventory added to the ODOC cabinet at step407. This step is described in more detail in FIG. 24, beginning withthe receipt of the shipped inventory at the hospital in step 450. Instep 451, the contents of the shipment is reconciled with the purchaseorder. This may be done for example, by the SRM bar code scanninginventory which has bar codes or in the case where the inventory hasindividualized RFID tags, bringing the inventory within the scanningradius of an RFID reader. In step 452, the destination for each item isdetermined, e.g., the SRM enters the specific ODOC cabinet in which theitem is being stored. In step 454, the SIGHT system is given notice ofthe inventory being received at the hospital and the SIGHT system instep 455 receives the stock location (e.g., the specific ODOC cabinet)for each item of inventory. In step 453, the SRM loads the appropriateODOC cabinet with the scheduled inventory items. Whether the SRM scansthe inventory bar codes at the cabinet or a cabinet RFID reader detectsRFID tags on the inventory items, the SIGHT system in step 456 may usethis information to verify that the inventory items have been loaded inthe ODOC cabinet.

FIG. 21, step 408 verifies the availability of consumable inventory(i.e., implant components) prior to surgery, with one specific procedureseen in FIG. 24. In FIG. 25 step 458, the SRM transmits to the SIGHTsystem the list of scheduled cases and the SIGHT system in turn providesthe scheduled cases and corresponding implant components required (i.e.,as determined previously in the selection procedure of FIGS. 12-16). Instep 460, the SRM confirms that the required implant components areavailable, e.g., (i.e., are located in the ODOC cabinet at the hospitalin question. Whether or not the implant components are in physicalinventory is transmitted to the SIGHT system in step 461 and step 462reconciles the results of the physical inventory check with the implantcomponents required in the procedure. If the necessary implantcomponents are not available at the hospital in question, the SIGHTsystem will order the needed additional inventory (e.g., see FIG. 23 forordering implant inventory). In certain embodiments, if the requiredinventory cannot be obtained or other necessary requirements for surgeryare missing or not confirmed in the system (e.g., required test resultsor acceptable payment/reimbursement information), then the systemgenerates and sends notices of the missing/unconfirmed requirements torelevant entities, e.g., the surgeon, the hospital, the patient, etc. sothat the requirements may be fulfilled or the surgery re-scheduled.

Thus, the above system provides another method embodiment for managingimplants. The system includes (i) an implant storage space, (ii) astorage sensor located proximate the storage space, the storage sensorconfigured to detect implant components, and (iii) a system computercommunicating with the storage sensor. The method involves firstdetermining a set of implant components scheduled to depart the storagespace; then removing from the storage space the set of implantcomponents scheduled to depart the storage space; and finally, operatingthe storage sensor to communicate to the computer system that the set ofimplant components have been removed from the storage space.

In FIG. 21, step 409, the implant components are transferred to thedeployment cart (i.e., cart 330 above) as described in more detail inFIG. 26. In step 465, the SRM requests a schedule of cases (typicallyfor a particular day, but possibly for a longer period of time) fromboth the SIGHT system and the hospital electronic medical records (emr)and the SRM in step 468 reconciles any differences in the scheduling,either manually or automatically using appropriate scheduling software.With the confirmed cases, a “pick list” of required implant componentsis generated for each case along with the particular ODOC cabinets (ifmore than one on site) from which the implant components are to bewithdrawn. Steps 471 and 472 address the SRM withdrawing the implantcomponents from the cabinet and adding them to the cart (which isdescribed in more detail above in reference to FIG. 20C). In the typicalcase, prior to the cart being wheeled to the operating room (i.e., thecart's scheduled destination) as per step 473, implant instruments andsurgical instruments will be added to the cart in accordance with steps410 and 411 in FIG. 21.

Step 410's verification of instrument (i.e., implant instruments andsurgical instruments) availability is described in more detail in FIG.27, steps 490 to 492. In step 490, the SRM selects the list of scheduledcases, which includes the surgeon name, from which the SIGHT system mayaccess the previously stored surgeon profile. In step 491 the SIGHTsystem provides a suggested set of implant instruments and surgicalinstruments based on a reduction process such as described above inreference to FIGS. 12 to 16. In step 492, the SRM (or the implantingsurgeon) confirms whether he or she wishes to utilize the instrument setsuggested by the SIGHT system or modify any particulars of theinstrument set. Next in step 493, the instruments are assembled into oneor more trays and then sterilized in step 494. The assembly of the traysin step 493 may include ordering the instruments in the trays.Alternatively, the instruments may be placed in the trays in anunordered fashion, to be place in order after the trays have reached theOR. Step 495 involves the inclusion of a series of instrument images andwritten instructions indicating the order in which the instruments areto be laid out and utilized in the OR, e.g., similar to the images anddescription seen in FIGS. 15C and 15D. Next the tray(s) of instrumentswill be place on a deployment cart 330 in step 496 (which may be thesame or a different cart from the one carrying the implant components).Step 497 involves the scanning of the label on the tray by the cartscanner, thereby confirming (in step 498) that the tray has been placedon the cart. After the cart is wheeled to the OR and the tray(s) removedfrom the cart (steps 499 and 500), there is another scan of the tray(s)by either a scanner on the cart or a separate scanner in the OR whichconfirms to the local SIGHT server that the tray(s) have reached the OR.In the case of the scanner on the cart, the cart's location in the OR issent with confirmation that the tray(s) have been read by the scanner.Step 502 again confirms that the tray(s) reaching the OR match theparticular patient schedule for surgery at that time and in that OR.Typically upon arrival of the tray(s), the instruments will be laid outon a surgical table (or “back table”) located in the OR. In step 503, ascrub tech or other OR personnel can confirm the instrument layoutmatches that shown in the images and written materials included in step495.

Since the system computer is communicating with the storage sensor(e.g., bar code scanner at storage cabinet) and the deployment sensor(e.g., bar code scanner at the cart), the system may carry out a seriesof steps such as (i) receiving data representing a set of implantcomponents scheduled to depart the implant storage space; (ii) receivingdata indicating that the storage sensor has detected the set of implantcomponents; and then (iii) receiving data indicating that the deploymentsensor has detected the set of implant components at a scheduleddestination. In this example, the “schedule destination” may be the OR(as suggested in step 473 of FIG. 26). In certain embodiments, the cartmay include a “locator device” or a method by which the system candetermine the approximate location of the cart. The locator device maybe GPS or it may be a device that triangulates RF signals sent orreceived by the cart. This would allow the system to determine when thecart has reached the OR or another scheduled destination.

In FIG. 21, step 412, the system dispenses or deploys the inventoryduring surgery as described in more detail in FIG. 28. In FIG. 28, step510, the surgeon, who at this stage has exposed and directly measuredthe patient's femur, now makes a decision on which femoral componenttrial size to utilize. It will be remember that the implantcomponent/instrument reduction process in FIGS. 12 to 16 contemplates apredicted size of implant components/instruments and the sizesimmediately above and below the predicted size. Once a femoral componenttrial size is selected, the system in step 511 will suggest compatibletrials for the tibial component and patellar component usingmanufacturer information concerning which tibial component and patellarcomponent are compatible with the selected femoral component. In steps512 and 513, the surgeon makes his or her choice of tibial baseplate andinsert trials and that decision is entered into the system. In step 514,the SIGHT system indicates whether (based upon manufacturer information)the selected tibial insert trials are compatible with other componentsselected by the surgeon. In step 515, the surgeon makes the finaldetermination on the compatibility of the trials and other components.In step 516, the surgeon verifies all selected trials by assembly on thepatient's prepared femur and tibia and performing a trail reductionrange of motion. Based on the verified trials, the corresponding implantcomponents are identified in step 517 and this information is enteredinto the SIGHT system by a “circulator” or other OR personnel outsidethe sterile field in step 518. Typically this individual will nextwithdraw from the cart the appropriate boxes containing the implantcomponents in step 519 and in step 520, these boxes of implants areagain scanned to maintain a record of which implants components weretaken from the cart for ultimate implantation in the patient. In step521, the SIGHT system confirms that the implant components just scannedcorrespond with the trials which were identified in step 518. Finally,the box is opened in step 522 and in step 523 the appropriate ORpersonnel is requested to identify whether components from open boxesare actually implanted into a patient or become wasted parts (e.g., theimplant component box was inadvertently opened or that particularimplant component must be rejected for reasons such as beingcontaminated prior to implantation). Finally, step 524 directs allunused cart inventory be returned to stock status for future use.

Returning to FIG. 21, after the instruments are deployed for surgery instep 412, the instruments are processed post-operatively in step 413 asillustrated in more detail in FIG. 29. First the instruments arereturned to their originating tray in step 530. Next the instruments aretransported to the hospital's central sterilization facility and cleanedin steps 531 and 532. In steps 533 the SRM confirms no instruments aremissing and that all appear in working order. The SRM then restocks theinstruments, replacing any that are missing or damaged, and scans thebar codes on the instruments in step 534. Alternatively, andparticularly with instruments too small to carry a bar code or RFID tag,the system could use a computer vision system to identify instruments tobe restocked (or otherwise being tracked within the SIGHT system). Withthe SIGHT system receiving the scanned bar codes, the system may updateits instrument inventory list in step 535. In FIG. 21, step 414, theSIGHT is able to generate reports on usage, such as implant sizesutilized, time of instrument usage in OR, surgeon instrumentpreferences, etc. In step 415, the SIGHT system will replenish inventorysupply to a level necessary to accommodate the expected use through aspecified period of time, i.e., with the inventory order method similarto that described in FIG. 23. In certain embodiments, the systemdetermines an implant components expiration date (e.g., either fromprompting the SRM to enter that date or obtaining the date frommanufacturer codes). The system can then give notice when the implantcomponent needs to be replace in inventory due to reaching itsexpiration date. Similarly, where sterilized implant instruments andsurgical instruments should be used within a given time period of theirlatest sterilization, the system can give notices when the sterilizationtime period has expired based upon when the instruments were loaded into the ODOC cabinet.

Although the inventive concept has been described in terms of certainspecific examples, many obvious variations and alternatives will beapparent to those skilled in the art. For example, in one embodiment ofthis invention, all of the surgical instruments, implant instruments,and implant components are marked for easy identification with bar codesor radio frequency identification tags to ensure the correct instrumentor component is selected to be transported to the operating room andselected at the proper time during the surgery based upon thedeterminations made as part of this invention.

In another embodiment of this invention, all of the surgicalinstruments, implant instruments, and implant components could beaffirmatively identified using a camera or vision sensor which isinterfaced to a computer with a database of visual images of suchsurgical instruments and components to positively identify eachinstrument or component is selected to be transported to the operatingroom and selected at the proper time during the surgery based upon thedeterminations made as part of this invention.

A further embodiment is a method of assisting an orthopedic implantprocedure in an operating room with an instrument table. The methodinvolves printing on a flexible media a sub-set of surgical instrumentsand implant instruments arranged into a substantially specific orderbased upon a determination of a sequence of bone cuts to be performed inthe procedure. The flexible media may be a paper, plastic, or clothe(e.g., a surgical drape). The flexible media is placed on the instrumenttable, and then OR personnel may arrange the surgical instruments andimplant instruments based on the order shown on the flexible media.

Another method embodiment is assisting an orthopedic implant procedurein an operating room takes place in an environment where there is (i) asurgical table in the operating room, (ii) a camera viewing the surgicaltable, and (iii) a computer receiving images from the camera. The methodloads into memory of the computer a sub-set of surgical instruments andimplant instruments arranged into a substantially specific order. ORpersonnel place the sub-set of surgical instruments and implantinstruments on the surgical table. The computer captures an image withthe camera of the surgical instruments and implant instruments on thesurgical table, and then determines which of the surgical instrumentsand implant instruments loaded into the computer memory are present inthe image of surgical instruments and implant instruments.

All such variations and alternatives should be considered part of thepresent invention and to fall within the scope of the below claims.

The invention claimed is:
 1. A method of assisting an orthopedic implantprocedure in an operating room with a display communicating with acomputer system, the method comprising the steps of: a. loading on thecomputer system a sub-set of surgical instruments and implantinstruments arranged into a substantially specific order based upon adetermination of a sequence of bone cuts to be performed in theprocedure; b. presenting on the display images of the surgicalinstruments and implant instruments in the substantially specific order;c. on the display, advancing through the substantially specific order ofthe surgical instruments and implant instruments; d. wherein a userinterface to the computer system is located in the operating room andthe user interface allows a user to control the computer system'sadvancement though the substantially specific order on the display; e.providing (i) a surgical table in the operating room, (ii) a cameraviewing the surgical table, and (iii) the computer system receivingimages from the camera; f. loading into memory of the computer system asub-set of surgical instruments and implant instruments arranged into asubstantially specific order; g. placing the sub-set of surgicalinstruments and implant instruments on the surgical table; h. capturingan image with the camera of the surgical instruments and implantinstruments on the surgical table; and i. determining which of thesurgical instruments and implant instruments loaded into the computermemory are present in the image of surgical instruments and implantinstruments.
 2. The method of claim 1, wherein the surgical instrumentsare bone cutting/alignment instruments.
 3. The method of claim 1 whereinthe surgical instruments and implant instruments are presented on thedisplay in separate groups associated with discrete steps in the implantprocedure.
 4. The method of claim 3 wherein the discrete steps in theimplant procedure are from the group consisting of: (i) FemoralAlignment, (ii) Distal Femoral Cut, (iii) Tibial Alignment, (iv)Proximal Tibial Cut, (v) Extension Gap Confirmation, (vi) Femoral CompSizing/Positioning, (vii) Anterior Femoral Cut, (viii) Posterior FemoralCut, (ix)Flexion Gap Confirmation, (x) Anterior Chamfer Femoral Cut,(xi) Posterior Chamfer Femoral Cut, (xii) Patella Resurfacing Cut,(xiii) Femoral Comp Finishing, (xiv) Femoral Comp Trialing, (xv) TibialBaseplate & Insert Trialing, (xvi) Patella Comp Finishing, (xvii)Patellar Comp Trialing, (xviii) ROM - Trial Reduction, (xix) TibialBaseplate Finishing, (xx) Femoral Comp Fixation, (xxi) Tibial BaseplateFixation, (xxii) Patellar Comp Fixation, (xxiii) Tibial InsertInsertion.
 5. The method of claim 1, wherein the set of implantinstruments include at least one from the group consisting of a femoraldrill guide, a femoral trial, a tibial baseplate trial, a tibial inserttrail, and a patellar drill guide.
 6. The method of claim 5, wherein theset of surgical instruments includes at least one from the groupconsisting of a femoral IM cutting guide, a femoral alignment guide, atibial IM alignment guide, a tibial cutting guide, a patellar caliper, apatellar resection guide, and an implant impactor.
 7. The method ofclaim 1 further comprising the step of generating a visual list of thesurgical instruments in the substantially specific order.